CLVS - EMA recommends restricted use of Clovis cancer drug

• The European Medicines Agency (EMA) announced on Friday Rubraca (rucaparib camsylate), a cancer medication marketed by the U.S. biotech Clovis Oncology ( NASDAQ: CLVS ) should no longer be used as a third line treatment for certain cancers due to concerns over safety/quality.
• Per the recommendation of the EMA’s Committee for Medicinal Products for Human Use (CHMP), the drug, also known as rucaparib camsylate will not be indicated as a third line option for certain patients with cancers in the ovary, fallopian tubes or peritoneum with a BRCA mutation.
• The decision follows a review on the quality, safety and efficacy issues of the treatment, EMA added.
• In 2018, the EU regulators granted conditional marketing authorization for Rubraca as a third line option for certain patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.
• Previously, the oral small molecule inhibitor was authorized in Europe for certain patients in the recurrent ovarian cancer maintenance setting regardless of their BRCA mutation status.

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